Research & Development
AbbVie's EPKINLYTM (epcoritamab-bysp) receives FDA approval
22 May 2023 -

AbbVie (NYSE: ABBV), a United States-based pharmaceutical company, announced on Friday that it has received approval from the US Food and Drug Administration (FDA) for its EPKINLYTM (epcoritamab-bysp), as the first and only T-cell engaging bispecific antibody intended for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B–cell lymphoma (HGBL), after two or more lines of systemic therapies.

EPKINLY has been approved under the FDA's Accelerated Approval program based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. EPKINLY is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration.

The product received approval based on Phase 1/2 EPCORE NHL-1 clinical trial and on patient response data and is also undergoing a study to confirm its clinical benefit. It is unclear if the product is safe and effective in children.